Kornimate/medical-research-clean huggingface dataset:
car-t for r/r malignant tumors in children

Conditions: CAR-T; Child, Only; Malignant Tumor

Summary: this study is a clinical study of car-t treatment of patients with relapsed/refractory malignant tumors in children. the purpose is to evaluate the safety and effectiveness of chimeric antigen receptor t cells in the treatment of relapsed/refractory malignant tumors in children.


Eligibility criteria:
inclusion criteria: * age 3-18 * expected survival time ≥ 12weeks * ecog 0-2 * at least second-line or above chemotherapy failed * liver and kidney function, heart and lung function meet the following requirements: creatinine is within the normal range; left ventricular ejection fraction ≥ 45%; baseline blood oxygen saturation\>91%; total bilirubin≤1.5×uln; alt and ast≤2.5×uln * understand the trial and have signed the informed consent exclusion criteria: * those who have graft-versus-host disease (gvhd) or need to use immunosuppressive agents * hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab) positive and peripheral blood hbv dna titer test is not within the normal reference range; hepatitis c virus (hcv) antibody positive and peripheral blood hcv rna positive; human immunodeficiency virus (hiv) antibody positive; cmv dna test positive; syphilis test positive * severe heart disease * systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication * within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections) * those who have received car-t therapy or other genetically modified cell therapy before screening * according to the researcher's judgment, it does not meet the situation of cell preparation * situations that other researchers think are not suitable for inclusion
the clasp study edwards pascal transcatheter mitral valve repair system study

Conditions: Mitral Valve Regurgitation

Summary: the purpose of this study is to assess the safety, performance and clinical outcomes of the edwards pascal transcatheter mitral valve repair (tmvr) system.

the purpose of this study is to assess the safety, performance and clinical outcomes of the edwards pascal transcatheter mitral valve repair (tmvr) system. this is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.

Eligibility criteria:
inclusion criteria: * signed and dated irb/ethics committee approved study consent form prior to study related procedures * eighteen (18) years of age or older * new york heart association (nyha) functional class ii-iva heart failure despite optimal medical therapy * candidacy for surgical mitral valve repair or replacement determined by heart team evaluation * clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (tee) and transthoracic echocardiography (tte). * the primary regurgitant jet is non-commissural. if a secondary jet exists, it must be considered clinically insignificant. * mitral valve area (mva) ≥ 4.0 cm² as measured by planimetry. if mva by planimetry is not measurable, pressure half-time measurement is acceptable. exclusion criteria: * patient in whom a tee is contraindicated or screening tee is unsuccessful * leaflet anatomy which may preclude pascal device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation. * mitral valve area (mva) \< 4.0 cm² as measured by planimetry (if mva by planimetry is not measurable, pht measurement is acceptable) * echocardiographic evidence of intracardiac mass, thrombus, or vegetation * physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction * concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator * patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment * patient is under guardianship
usability of blood glucose control with the space tgc system in medical icu patients

Conditions: Critical Illness

Summary: hyperglycemia is common in critically ill patients and associated with an adverse outcome. thus, glycaemic control is an important issue in critical care. despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. a fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. space glucosecontrol (tgc system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. information on parenteral and enteral nutrition is automatically integrated into the calculations. the primary objective of the current study is to investigate the performance and usability of the space tgc system for glucose control in medical icu patients.


Eligibility criteria:
inclusion: * age: \> 18 years of age * stay in the icu expected to be \> 72 h * blood glucose \> 6.1 mmol/l or patient on insulin treatment exclusion: * patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency. * known or suspected allergy to insulin * any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures) * moribund patients likely to die within 24 hours

Keywords: algorithm tight glycemic control glucose control intensive care insulin icu
impulse™ una full-spectrum, over clothing e-stethoscope

Conditions: Corona Virus Infection; Coronavirus

Summary: this study generates robust clinical data to train ml/ai algorithms of the sponsor's impulse™ una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic sars-cov-2/covid-19 biosignatures for rapid and accurate mass screening.

this study is designed to evaluate the ability of the impulse™ una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed covid-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the impulse™ una device for early and rapid, point-of-care diagnosis of covid-19. this will inform the utility and design of further larger-scale studies using the device.

Eligibility criteria:
inclusion criteria * individuals hospitalized within a johns hopkins-affiliated hospital * able to understand and willingness to comply with study procedures * cases - inpatients with positive covid-19 pcr test, collected from a respiratory sample within the last 7 days, and pulmonary symptoms within 72 hours of enrollment * controls - inpatients without covid-19 diagnosis and no pulmonary diagnosis or symptoms * cases or control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing. exclusion criteria * assisted ventilation, including high flow nasal cannula, or ventilator support * unable to comply with study procedures, defined at investigator's discretion * participants with any visible skin infections or open wounds in areas where the impulse™ una device would be applied

Keywords: infrasound e-stethoscope biosignature sars-cov-2/covid-19
does frailty help predict postoperative outcomes in cardiac surgery?

Conditions: Coronary Heart Disease; Heart Valve Diseases

Summary: this study will assess the benefit in using a frailty score to quantify accurate risk pre-operatively in patients undergoing major cardiac surgery in order to predict morbidity and disability-free survival post-operatively.

increasingly, the group of patients undergoing cardiac surgery are older. patients that are more elderly and frail are known to have an increase risk of injury to major organs following surgery including the heart, kidneys, and brain, all of which are associated with worse survival or diminished quality of life. it is becoming more important to be able to predict how well patients will fair in cardiac surgery, including predicting risk of complications (such as stroke or heart attacks) as well as long-term survival and quality of life. currently, scores such as euroscore can be used with good effect in predicting survival and major complications in cardiac surgery patients. however, frailty - the severity of a patient's weakness or fragility - has emerged as a potential candidate in predicting risk. recent research has shown frailty score to predict risk of survival and complications following cardiac surgery and suggested to be possibly superior to pre-existing scores. the investigators wish to investigate the possible link between frailty and outcomes following cardiac surgery, in addition to current risk scores. the investigators also wish to determine whether frailty can effectively predict longer-term outcomes such as 'disability-free survival' - a patient-centred score that measures the ability of a patient to lead normal life activities. patients undergoing major cardiac surgery at king's college hospital will be recruited, following consent. the study will mainly involve questionnaires at various stages, starting at a pre-operative clinic. after surgery, follow up of patient's progress will be carried out at 3 days in hospital; and at 1 month, 3 months, and 6 months and 1 year via telephone. the investigators expect the results of this observational study to influence further research into the use of frailty risk scoring prior to clinical decisions, and add to the evidence in assessing risk-related outcomes in cardiac surgery.

Eligibility criteria:
inclusion criteria: * aged 18 years or over * due to undergo elective cardiac surgery: coronary artery bypass graft (cabg); valve replacement/repair; or transcatheter aortic valve implantation (tavi) surgery * able to give informed consent * fluency in english exclusion criteria: * emergency cardiac surgery and non-cardiac surgery * inadequate knowledge of english that will prevent patients from completing the consent or undertaking study assessments * severe visual, auditory, or motor handicap * concurrent diseases of the central nervous system, * patients at the extremes of frailty, in whom it would be unethical to perform a full assessment.

Keywords: cardiac surgery frailty frail patients recovery morbidity outcomes mortality heart perioperative disability whodas
d-serine supplementation for depression

Conditions: Major Depressive Disorder

Summary: the glutamate system is emerging as target for the development of novel antidepressant medication, in particular compounds modulating the nmda receptor. while the nmda receptor antagonist ketamine is an effective option for many treatment-restistant patients, it is also accompanied by dissociative and cognitive effects and also bears the risk to develop addiction, side effects that are significantly restricting its clinical utility. there is now compelling evidence of the antidepressant potential of d-serine, a nmdar co-agonist. compared to ketamine, d-serine goes along without any psychotomimetic effects or other side effects and thus might be a prom-ising novel antidepressant. this study represents the first randomized control trial to test the efficacy of d-serine as an adjuvant therapy in patients with depression and thereby adds to re-cent efforts to establish novel glutamatergic antidepressants. besides clinical measures, this study also explores the biological mechanisms underlying d-serine's clinical effect.


Eligibility criteria:
inclusion criteria: * age 18-60 * inpatients with a diagnosis of mdd with a current moderate-to-severe episode (ham-d score \> 16) (7) * treatment as usual (tau) for depression. tau for depression may include no treatment at all or standard pharmacotherapy (antidepressants and antipsychotics such as aripiprazole, risperidone or quetiapine) and / or psychotherapy. * able to read and understand study procedures and participant's information exclusion criteria: * other primary psychiatric diagnoses than mdd such as substance use and psychotic disorders * serious suicide attempts * contradiction for mri (no pacemaker, mri incompatible metal implants or splinters in the body, past heart/head surgery, past stroke/brain injury, claustrophobia) * pregnant or lactating women (pregnancy test)
effect of pbi-4050 on the pharmacokinetics of midazolam in heathy adult subjects

Conditions: Healthy

Summary: this study is designed to evaluate the pharmacokinetics (pk) and safety of multiple doses of pbi-4050 combined with midazolam in healthy adult subjects.

this is a phase 1, single-center, open-label, 2-period, fixed sequence study to investigate the effect of multiple doses of pbi-4050 on the pk of midazolam, a cytochrome p450 (cyp) 3a substrate, in healthy adult men and healthy women of non-childbearing potential (woncbp), and to determine the safety and tolerability of pbi-4050, when co-administered with midazolam. on day 1 of period 1, subjects will receive a single oral dose of midazolam followed by pk sampling of midazolam and its metabolite 1-hydroxymidazolam (1-oh-midazolam). in period 2, subjects will receive multiple daily doses of pbi-4050 for 5 consecutive days (day 1 to day 5) with a single oral dose of midazolam co-administered on day 5. pk sampling for midazolam and 1-oh-midazolam will be collected for 24 hours following dosing on day 5. pk sampling for pbi-4050 and its major metabolite will be collected at pre-dose on days 3, 4, and 5. there will be a washout period of at least 2 days between midazolam dose in period 1 and the first pbi-4050 dose in period 2.

Eligibility criteria:
inclusion criteria: 1. males or females (woncbp only). 2. age 18-65 years. 3. continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing. 4. body mass index (bmi) ≥ 18.0 and ≤ 32.0 kg/m2 at screening. 5. generally good health. 6. males willing to use appropriate contraception. exclusion criteria: 1. significant medical history or physical findings. 2. history or presence of drug allergy or hypersensitivity to treatment ingredients. 3. gastrointestinal surgery. 4. pregnant or lactating. 5. positive urine drug or alcohol screen. 6. abnormal heart rate or blood pressure. 7. prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety. • receiving drugs known as significant inducers of cyp2c9, cyp3a4, cyp2c8 and/or cyp1a2 enzymes and/or p-glycoprotein, including st. john's wort, for 28 days prior to the first dosing and throughout the study. 8. has been on a diet incompatible with the on-study diet. 9. recent blood donation or significant blood loss. 10. recent blood received. 11. participation in another clinical study within 30 days prior to the first.

Keywords: pbi-4050 drug-drug interaction cyp3a midazolam healthy subjects
what treatment works for children with selective mutism?

Conditions: Selective Mutism

Summary: the purpose of this pilot study is to explore the outcome of a manual based treatment for children with selective mutism

objectives: the main aim of this pilot study is to increase our knowledge on interventions for selective mutism (sm), a childhood condition characterized by a persistent lack of speech in specific situations despite the ability to comprehend and use language. a survey on the treatment offered this group in norway 1997-2000 showed great variations in therapeutic approach and the overall outcome was poor. correspondent with the notion of sm as a variant of social anxiety, several case studies have described successful treatments using behaviour techniques (bt's) such as stimulus fading and shaping. in addition, the author's clinical experience is that "defocusing in communication" (e.g. regulation of gaze contact; sitting beside instead of in front of the child, avoiding direct questioning, talking about interesting but impersonal topics) represents another important toil in getting the mute child to start talking. however, to date there are no randomized controlled sm treatment studies, and in fact we know little of what works best to help these children. our research group has developed an assessment- and treatment manual for children with sm. in this exploring pilot study referred children with sm aged 3-5 years (n=7) will be given an intervention according to the treatment manual. the intervention is conducted at home and in the kindergarten or at school and includes stimulus fading techniques with weekly sessions. therapists will be members of the research group or local therapist under supervision.

Eligibility criteria:
inclusion criteria: * children with a clinical diagnosis of selective mutism (sm) exclusion criteria: * children with mental retardation (iq\<50) * children with pervasive developmental disorder (pdd) * children with sm in active treatment * children with sm on medication * children whose parents are non-norwegian speaking

Keywords: selective mutism children treatment
study of antioxidants on mri detectable early stage prostate cancer among men on active surveillance

Conditions: Cancer of the Prostate; Prostate Cancer; Prostatic Neoplasms

Summary: the purpose of this study is to determine whether antioxidants (vitamin e, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by mri imaging among men on active surveillance.


Eligibility criteria:
inclusion criteria: * mri detectable prostate cancer * psa less than 15 ng/ml * gleason score \<= 7 * prostate cancer staging t1c or t2a exclusion criteria: * concurrent use of high-dose vitamins which include selenium, lycopene, vitamin d or vitamin e * other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma) * current use of proscar or avodart

Keywords: male urogenital diseases antioxidants vitamin e vitamin d lycopene selenium
s9716: combination chemotherapy in treating patients with merkel cell cancer

Conditions: Neuroendocrine Carcinoma of the Skin

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining cyclophosphamide, methotrexate, and fluorouracil in treating patients with merkel cell cancer.

objectives: i. investigate the ability of the southwest oncology group melanoma committee to enroll patients with unresectable merkel cell carcinoma that is local-regional or metastatic. ii. determine the overall survival rate and objective response rate of these patients after treatment with cyclophosphamide, methotrexate, and fluorouracil. outline: patients are stratified according to local-regional disease versus metastatic disease. patients receive cyclophosphamide iv, methotrexate iv, and fluorouracil iv on day 1. courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicities. patients are followed every 6 months for 2 years, then annually thereafter. projected accrual: a total of 80 patients (40 patients per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven unresectable merkel cell carcinoma local-regional or metastatic bidimensionally measurable disease if all known sites previously irradiated, disease must be progressive cns metastases allowed if not only site of measurable disease no pleural effusions or ascites patient characteristics: age: 18 and over performance status: swog 0-2 life expectancy: not specified hematopoietic: absolute granulocyte count at least 1500/mm3 platelet count at least 100,000/mm3 hepatic: not specified renal: not specified other: not pregnant or nursing fertile patients must use effective contraception no other prior malignancy within 5 years except: adequately treated basal cell or squamous cell skin cancer adequately treated stage i or ii cancer in situ cervical cancer prior concurrent therapy: biologic therapy: no prior biologic therapy or immunotherapy no concurrent immunotherapy chemotherapy: no prior chemotherapy for metastatic disease at least 4 weeks since prior adjuvant chemotherapy no prior adjuvant cyclophosphamide, methotrexate, or fluorouracil no other concurrent chemotherapy endocrine therapy: no concurrent hormone therapy radiotherapy: see disease characteristics at least 14 days since prior radiotherapy surgery: at least 2 weeks since prior surgery

Keywords: stage ii neuroendocrine carcinoma of the skin stage iii neuroendocrine carcinoma of the skin recurrent neuroendocrine carcinoma of the skin
neuropsychological and brain medical imaging study in patients with brain damage

Conditions: Cerebrovascular Disorders; Brain Lesions; Degenerative Diseases; Developmental Pathology

Summary: two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative disorders and selective cognitive disorders; (ii) healthy control subjects. the objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * french language * effective contraception for women during the study * informed consent * no alcohol intake the day before the exam * for patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology or degenerative disease with cognitive deficit exclusion criteria: * for healthy volunteers: previous neurological history (except non complicated migraine), previous psychiatric history (except depression with good evolution or anxiety with maximum one anxiolytic treatment), or severe cranial traumatism * for patients: vigilance disorders, severe depression or anxiety. * for both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for mri, participation in another trial or former involvement in another trial within one month

Keywords: neuropsychological study brain imaging